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NCT05036135 (AV-101 in Pulmonary Arterial Hypertension): BVCT ex-ante prediction vs. reported outcome

On 27 Jan 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 17 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05036135
Acronym
IMPAHCT
Drug Name
AV-101
Drug MoA
inhaled imatinib as a tyrosine kinase inhibitor
Drug Modality
dry powder inhaled formulation
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Pulmonary Arterial Hypertension
Human Patients
462
Sponsor
Aerovate Therapeutics
Phase
Phase 2 Phase 3

Prediction of , index 1440

Prospective Prediction
Prediction Index
1440
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in PVR); partial FAILURE (statistically insignificant clinical benefit in 6MWD)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
142 days in advance
Readout Data Interpretation
no dose met the primary efficacy endpoint PVR and no dose achieved minimally clinical meaningful improvement in 6MWD (30 meters).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH)
Phase
Phase 2, Phase 3
Status
Terminated
Enrollment
202
Lead sponsor
Aerovate Therapeutics
Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG: AV-101; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-12-02
Primary completion
2024-08-09
Completion
2024-08-09
Primary outcomes
  • Phase 2b: Change from Baseline in Pulmonary Vascular Resistance (PVR) (24 weeks)
  • Phase 3: Change from Baseline in Six Minute Walk Distance (6MWD) (24 weeks)

NCT05036135 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials